Cooled RF Lesion MRI Characteristics

Osteo Arthritis Knee Clinical Trial

Official title:

A Prospective, Single-center, Pilot Study of in Vivo Lesion Characteristics Post Coolief Cooled Radiofrequency Denervation as a Treatment for Chronic Pain

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03631030
• Other study ID #: 105-17-0004
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 25, 2018
• Est. completion date: January 2020

Study information

• Verified date: August 2019
• Source: International Spine, Pain and Performance Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This Prospective, Single-center, Pilot Study will assist in gaining an understanding of the actual CRFA lesions in an in vivo situation in areas where CRFA is utilized as a standard of care treatment option for the relief of chronic pain (cervical facet joints, thoracic facet joints, lumbar facet joints, Sacroiliac (SI) region, hip and knee).

Description:

This study will be a prospective, single-center, pilot study. Adult subjects over the age 21 diagnosed with chronic joint pain (≥ 3 months), scheduled to receive Radiofrequency denervation and meet the selection criteria are eligible to participate in this study. The specific targeted areas of interest in this study will include Cervical facet joints, Thoracic facet joints, Lumbar facet joints, Sacroiliac (SI) region, hip and knee.

The treating physician will follow Standard of Care treatment for all enrolled subjects. As illustrated in Figure 1, the study consists of a screening visit, a treatment visit and a follow up visit. All subjects receiving CRFA will receive an MRI 2 - 7 days after the CRFA procedure. Subjects receiving CRFA of the Sacroiliac Joint will also receive an MRI within 30 days prior to the CRFA procedure. The treating physician may also request an MRI be performed prior to the procedure for subjects receiving CRFA of other targeted areas. The point of enrollment for each subject is the time that they sign the Informed Consent Form.

MRI data will be reviewed by the radiologist on a per patient basis to confirm lesion characteristics. It is anticipated that 3-5 subjects per level will be needed to fully quantify lesion characteristics, however; enrollment will remain flexible for each targeted area based on real time review of MRI data.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Age = 21 years

2. Able to understand the informed consent form and provide written informed consent and able to complete outcome measures.

3. Must be clinically appropriate candidate to receive CRFA for treatment of chronic pain.

4. Willing and able to receive an MRI

Exclusion Criteria:

1. Unable to receive an MRI (i.e. due to pacemaker or iron-based metal implant).

2. Unable to receive an MRI (i.e. iron-based metal implant).

3. Extremely thin patients and those with minimal subcutaneous tissue thickness that would not accommodate a radiofrequency lesion of up to 14mm in diameter to limit the risk of skin burns.

4. Active joint infection or systemic or localized infection at the needle entry site (subject may be considered for inclusion once infection is resolved.)

5. Subject currently implanted with a pacemaker or defibrillator

6. In the event a pre-treatment MRI is obtained; trauma or injury occurring to the targeted area between the baseline MRI and CRFA treatment

7. Subject unwillingness or unable to comply with protocol requirements

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Degenerative
• Arthritis;Lumbosacral
• Hip Osteoarthritis
• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee
• Sacroiliitis

Intervention

Device:
• Cooled radiofrequency ablation
Cooled Radiofrequency ablation (CRFA) is a well-established method for delivering lesions into nervous tissue to accomplish neurotomy procedures

Locations

Country	Name	City	State
United States	International Spine, Pain and Performance Center	Arlington	Virginia
United States	International Spine, and Performance Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
International Spine, Pain and Performance Center	Halyard Health

Country where clinical trial is conducted

United States, 

References & Publications (7)

Ho KY, Hadi MA, Pasutharnchat K, Tan KH. Cooled radiofrequency denervation for treatment of sacroiliac joint pain: two-year results from 20 cases. J Pain Res. 2013 Jul 4;6:505-11. doi: 10.2147/JPR.S46827. Print 2013. — View Citation

Kapural L, Mekhail N. Novel intradiscal biacuplasty (IDB) for the treatment of lumbar discogenic pain. Pain Pract. 2007 Jun;7(2):130-4. — View Citation

Kapural L, Stojanovic M, Sessler DI, Bensitel T, Zovkic P. Cooled radiofrequency (RF) of L5 dorsal ramus for RF denervation of the sacroiliac joint: technical report. Pain Med. 2010 Jan;11(1):53-7. doi: 10.1111/j.1526-4637.2009.00772.x. Epub 2009 Dec 16. Erratum in: Pain Med. 2010 Dec;11(12):1874. Sessler, Daniel I [added]. — View Citation

Kapural L, Vrooman B, Sarwar S, Krizanac-Bengez L, Rauck R, Gilmore C, North J, Girgis G, Mekhail N. A randomized, placebo-controlled trial of transdiscal radiofrequency, biacuplasty for treatment of discogenic lower back pain. Pain Med. 2013 Mar;14(3):362-73. doi: 10.1111/pme.12023. Epub 2012 Dec 28. — View Citation

Karaman H, Tüfek A, Kavak GÖ, Kaya S, Yildirim ZB, Uysal E, Celik F. 6-month results of TransDiscal Biacuplasty on patients with discogenic low back pain: preliminary findings. Int J Med Sci. 2010 Dec 14;8(1):1-8. — View Citation

Patel N, Gross A, Brown L, Gekht G. A randomized, placebo-controlled study to assess the efficacy of lateral branch neurotomy for chronic sacroiliac joint pain. Pain Med. 2012 Mar;13(3):383-98. doi: 10.1111/j.1526-4637.2012.01328.x. Epub 2012 Feb 2. — View Citation

Stelzer W, Aiglesberger M, Stelzer D, Stelzer V. Use of cooled radiofrequency lateral branch neurotomy for the treatment of sacroiliac joint-mediated low back pain: a large case series. Pain Med. 2013 Jan;14(1):29-35. doi: 10.1111/pme.12014. Epub 2012 Dec 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cooled radiofrequency ablation lesion size	Size in millimeters of cooled radiofrequency ablation lesion via MRI	MRI obtained between 2-7 days post-procedure.
Secondary	Pain relief	Compare pre-procedure and post-procedure change in pain using the numerical pain rating scale with 0 being no pain and 10 being the worst possible pain.	2-4 weeks post-procedure as compared to pre-procedure